Background: 

The aim of this two-center, all-comers registry was to compare the safety and effectiveness of intravascular lithotripsy (IVL) to that of debulking balloon angioplasty (DBA). DBA using a cutting or scoring balloon is commonly used in patients with calcified coronary arteries. IVL is a new technology for lesion preparation. This is the first study to compare DBA with IVL. 

Methods: 

The cohort included all patients treated by DBA or IVL between 2019 and 2021. The primary endpoint was strategy success (<20% residual stenosis). The secondary endpoint was long-term safety outcomes. Quantitative coronary angiography was performed in all patients. Primary and secondary endpoints were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation.

Results:  

A total of n=86 patients were treated by IVL and n=92 patients by DBA. The primary endpoint was reached in 152 patients (85.4%). Patients in the IVL group had less residual stenosis (5.8% vs. 22.8%; P=0.001). Weighted multivariate regression analysis revealed that IVL had a significant positive effect on reaching the primary end point (Odds ratio (OR) 24.58; 95% Confidence interval (CI) 7.40-101,49; P=0.001). In addition, severe calcification was shown to result in a lower probability of achieving the primary endpoint (OR 0.08; 95% CI 0.02-0.24; P=0.001).

During the follow-up period (450 days) there was no significant difference in cardiovascular mortality rate (IVL (n=5) 2.8% vs. DBA (n=3) 1.7%; P=0.129). Weighted univariate Cox proportional hazard analysis could also rule out a significant effect of IVL on cardiovascular mortality (P=0.074). Patients with unstable angina at time of the index procedure had the highest probability of cardiovascular death (Hazard Ratio (HR) 7.136; 95% CI 1.248-40.802; P=0.027). No significant differences were found in long-term rate of acute myocardial infarction (IVL 1.7% vs. DBA 2.8%; P=0.399; IVL HR 2.73; 95% CI 0.4-17.0; P=0.281) and target lesion failure/revascularization (IVL 5.6% vs. DBA 9%; P=0.186; IVL HR 0.78; 95% CI 0.277-2.166; P=0.626). 

Conclusion: 

IVL results in a significantly lower rate of residual stenosis than DBA. During the long-term follow-up, no differences in cardiovascular mortality, rate of acute myocardial infarction or target lesion failure/revascularization were observed.